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Charting Regulatory Stewardship in Health Research: Making the Invisible Visible

  • GRAEME T. LAURIE, EDWARD S. DOVE, AGOMONI GANGULI-MITRA, ISABEL FLETCHER, CATRIONA MCMILLAN, NAYHA SETHI and ANNIE SORBIE...
Extract

This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects.

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This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
References
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Notes

1. High Level Expert Group on the European Open Science Cloud. A Cloud on the 2020 Horizon: Realising the European Open Science Cloud: first report and recommendations, 2016; available at https://www.eudat.eu/sites/default/files/HLEG%20EOSC%20first%20Report.pdf (last accessed 28 Apr 2017).

2. Council of the European Union. Council conclusions on the transition towards an Open Science system. 9526/16 RECH 208 TELECOM 100, 2016; available at http://data.consilium.europa.eu/doc/document/ST-9526-2016-INIT/en/pdf (last accessed 28 Apr 2017).

3. Editorial. European Open Science Cloud. Nature Genetics 2016;48:821.

4. British Academy and the Royal Society. Data management and use: Governance in the 21st century, 2017; available at https://royalsociety.org/∼/media/policy/projects/data-governance/data-management-governance.pdf (last accessed 7 July 2017).

5. See note 1, High Level Expert Group on the European Open Science Cloud 2016.

6. Nuffield Council on Bioethics. Public health: Ethical issues, 2007; available at http://nuffieldbioethics.org/project/public-health/ (last accessed 28 Apr 2017).

7. See note 6, Nuffield Council on Bioethics 2007, at para. 2.44.

8. World Health Organisation. Health systems: Stewardship, c.2017; available at http://www.who.int/healthsystems/stewardship/en/ (last accessed 28 Apr 2017).

9. Jansen, LA. Between beneficence and justice: The ethics of stewardship in medicine. Journal of Medicine and Philosophy 2013;38(1):5063.

10. See note 9, Jansen 2013, at 51.

11. See note 9, Jansen 2013, at 62. Emphasis added.

12. See note 9, Jansen 2013, at 55.

13. See note 9, Jansen 2013, at 55.

14. Thomasma, DC. Stewardship of the aged: Meeting the ethical challenge of ageism. Cambridge Quarterly of Healthcare Ethics 1999;8:148–59, at 157.

15. Presidential Commission for the Study of Bioethical Issues. New directions: The ethics of synthetic biology and emerging technologies, 2010, at 4; available at http://bioethics.gov/sites/default/files/PCSBI-Synthetic-Biology-Report-12.16.10_0.pdf (last accessed 28 Apr 2017).

16. See note 15, Presidential Commission for the Study of Bioethical Issues 2010, at 8.

17. Laurie, GT, Harmon, SH. Through the thicket and across the divide: Successfully navigating the regulatory landscape in life sciences research. In: Cloatre, E, Pickersgill, M, eds. Knowledge, Technology and Law. Oxon: Routledge; 2014:121–36.

18. Academy of Medical Sciences. A new pathway for the regulation and governance of health research, 2011; available at http://www.acmedsci.ac.uk/policy/policy-projects/a-new-pathway-for-the-regulation-and-governance-of-health-research/ (last accessed 28 Apr 2017).

19. Chief Scientist Office. Delivering innovation through research—Scottish Government health and social care research strategy, 2015; available at http://www.gov.scot/Resource/0048/00488082.pdf (last accessed 28 Apr 2017).

20. Townend, D, Dove, ES, Nicol, D, Bovenberg, J, Knoppers, BM. Streamlining ethical review of data intensive research. British Medical Journal 2016;354:i4181.

21. Dove, ES, Townend, D, Meslin, E, Bobrow, M, Littler, K, Nicol, D, et al. Ethics review for international data-intensive research. Science 2016;351(6280):1399–400.

22. See note 18, Academy of Medical Sciences 2011. Also see the follow-up in 2012 that focused particularly on “streamlining”: Academy of Medical Sciences. Transforming the regulation and governance of health research in the UK, 2012; available at https://acmedsci.ac.uk/file-download/34885-51dd839626e27.pdf (last accessed 28 Apr 2017). The 5 year follow-up report was published in 2017: Academy of Medical Sciences. Regulation and governance of health research: Five years on, 2017; available at https://acmedsci.ac.uk/file-download/14145196 (last accessed 7 July 2017).

23. US Food and Drug Administration. Mutual recognition promises new framework for pharmaceutical inspections for United States and European Union, 2017; available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544357.htm (last accessed 28 Apr 2017).

24. Levine, A. Biomedical research: Privacy rules. Nature 2016;532:273–4.

25. Taylor-Alexander, S, Dove, ES, Fletcher, I, Ganguli-Mitra, A, McMillan, C, Laurie, GT. Beyond regulatory compression: confronting the liminal spaces of health research regulation. Law, Innovation and Technology 2016;8(2):149–76.

26. Laurie, GT. Liminality and the limits of law in health research regulation: what are we missing in the spaces in-between? Medical Law Review 2017;25(1):4772.

27. Bloomrosen, M, Detmer, D. Advancing the framework: Use of health data—a report of a working conference of the American Medical Informatics Association. JAMA 2008;15:715–22.

28. NHS Research Scotland. Research ethics structure in Scotland, c. 2012–17; available at http://www.nhsresearchscotland.org.uk/services/research-ethics (last accessed 28 Apr 2017).

29. Health Research Authority, c. 2013; available at http://www.hra.nhs.uk/ (last accessed 22 Oct 2016) and https://acmedsci.ac.uk/file-download/34273-5476048647169.pdf (last accessed 7 July 2017).

30. This quote has been extrapolated from 28 in-depth interviews conducted by one of us (E.S.D.) with health research regulators and research ethics committee members in England and Scotland. Interviews were conducted between January and July 2016.

31. See note 30.

32. UK Biobank Ethics and Governance Council. Ethics and Governance Framework, n.d. available at https://egcukbiobank.org.uk/Ethics-and-governance-framework (last accessed 6 Jun 2017).

33. UK Biobank. Access procedures: Application and review procedures for access to the UK Biobank Resource, 2011; available at http://www.ukbiobank.ac.uk/wp-content/uploads/2012/09/Access-Procedures-2011.pdf (last accessed 6 Jun 2017).

34. Council of the Canadian Academies. Accessing health and health-related data in Canada, c. 2011–16; available at http://www.scienceadvice.ca/en/assessments/completed/health-data.aspx (last accessed 22 Oct 2016).

35. State Sector Act 1988; available at http://www.legislation.govt.nz/act/public/1988/0020/latest/DLM129110.html (last accessed 28 Apr 2017).

36. Care Act 2014; available at http://www.legislation.gov.uk/ukpga/2014/23/contents/enacted/data.htm (last accessed 28 Apr 2017).

37. Guillemin, M, Gillam, L, Rosenthal, D, Bolitho, S. Human research ethics committees: examining their roles and practices. Journal of Empirical Research on Human Research Ethics 2012;7(3):3849.

38. National Data Guardian for Health and Care. Review of data security, consent and opt-outs, 2016. Recommendations 2 and 8; available at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/535024/data-security-review.PDF (last accessed 28 Apr 2017).

39. Kenny C. Making a mess professionally. Good Doctors, 2016; available at https://www.gooddoctors.org.uk/making-a-mess-professionally/?platform=hootsuite (accessed 22 Oct 2016).

40. Stephens, N, Atkinson, P, Glasner, P. Documenting the doable and doing the documented: bridging strategies at the UK Stem Cell Bank. Social Studies of Science 2011;41:791813.

41. Sethi, N, Laurie, G. Delivering proportionate governance in the era of eHealth. Making linkage and privacy work together. Medical Law International 2013;13:168204.

42. See note 3, Editorial 2016.

43. Ganguli-Mitra, A, Dove, ES, Laurie, G, Taylor-Alexander, S. Reconfiguring social value in health research through the lens of liminality. Bioethics 2017;31;8796.

We thank Dr. Samuel Taylor-Alexander, Monash University, for his contributions to early drafts of this article. This article is based on research conducted with support from a Wellcome Senior Investigator Award entitled “Confronting the Liminal Spaces of Health Research Regulation” (Award No: WT103360MA): http://www.liminalspaces.ed.ac.uk/. All authors contributed to the development and authorship of this article. The order of authorship reflects the degree of input. There are no competing interests.

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Cambridge Quarterly of Healthcare Ethics
  • ISSN: 0963-1801
  • EISSN: 1469-2147
  • URL: /core/journals/cambridge-quarterly-of-healthcare-ethics
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